Ryan v. Young, Int. 105,504, Paper 116 (March 4, 2008) [Interferences - general motion practice]•Ryan v. Young
Ryan v. Young
Ryan v. Young, Int. 105,504, Paper 116 (March 4, 2008) [Interferences - general motion practice]Ptab Interferences
Texto completo
Filed by: Paper: 116 Motions Panel Entered: 4 March 2008 BoxInterferences@uspto.gov Telephone: 571-272-4683 UNITED STATES PATENT AND TRADEMARK OFFICE BOARD OF PATENT APPEALS AND INTERFERENCES ____________________ Patent Interference 105,504 McK Patent Interference 105,505 McK Technology Center 1700 ____________________ WAYNE L. RYAN, Patent 6,723,563 B2, Patent 6,653,137 B2, Junior Party, v. CAROLE J. YOUNG, MICHAEL N. ELLIOTT, NANCY R. NAYLOR-SCHLIPP and TIMOTHY J. FISCHER Application 10/909,561, Application 10/909,594, Senior Party. ____________________ Before: FRED E. McKELVEY, Senior Administrative Patent Judge, and 1 RICHARD TORCZON and SALLY GARDNER LANE, Administrative 2 Patent Judges. 3 4 McKELVEY, Senior Administrative Patent Judge. 5 6 [AMENDED] DECISION ON MOTIONS 7
Consolidated Interferences 105,504 and 105,505 Decision of Motions 2 A. Statement of the case 1 The case is before a motions panel for entry of a decision on motions. 2 Oral argument was held on 19 September 2007. On 27 September 3 2007, an order was entered inviting the parties to submit additional briefing. 4 Paper 100. On 29 October 2007, the parties timely responded to the 5 invitation. Paper 104; Paper 106. Supplemental oral argument took place 6 on 01 November 2007. We express our gratitude to counsel, and their 7 respective clients, for responding to our invitation for additional briefing 8 and for attending the supplemental oral argument. 9 References to a "Paper" followed by a number are references to 10 entries in the file of Interference 105,504 unless otherwise noted. 11 Interference 105,504—Method of making control 12 Interference 105,504 was declared on 22 September 2006 (Paper 1). 13 The interference is between: 14 (1) Junior Party Wayne L. Ryan, based on U.S. Patent 15 6,723,563 B2, issued 20 April 2004 (first Ryan patent), 16 based on application 10/005,999, filed 03 December 17 2001 (first Ryan application), and 18 (2) Senior Party (a) Carole J. Young, (b) Michael N. Elliott, 19 (c) Nancy R. Naylor-Schlipp and (d) Timothy J. Fischer, 20 based on application 10/909,561, filed 02 August 2004 21 (first involved Young application). 22 The real party in interest for Ryan is Streck Laboratories, Inc. 23 The real party in interest for Young is Beckman Coulter, Inc. 24 Count 1 is the only count: 25
Consolidated Interferences 105,504 and 105,505 Decision of Motions 3 A method according to (1) any of claims 1, 2, 11 or 20 of 1 Ryan U.S. Patent 6,723,563 B2 or (2) any of claims 41, 50, 60, 2 69 or 86 of Young application 10/909,561. 3 Ryan claim 1 4 A method of making a control including a nucleated red 5 blood cell component comprising the steps of: 6 a) providing a blood cell suitable for simulating a 7 nucleated red blood cell, said blood cell including a membrane 8 enclosing nucleus and cytoplasm, and wherein said blood cell is 9 selected from the group consisting of reptile nucleated blood 10 cells and fish nucleated blood cells; 11 b) stabilizing said membrane of said blood cell with said 12 nucleus remaining therein to give a product; and 13 c) admixing the product of step b) in a suspension 14 medium suitable for delivering said product of step b to a 15 hematology analyzer for analysis. 16 Young claim 41 17 A method of making a control including a nucleated 18 blood cell component comprising the steps of: 19 a) providing a blood cell suitable for simulating a 20 nucleated blood cell, said blood cell including a membrane 21 enclosing nucleus and cytoplasm; 22 b) removing cytoplasm from within said membrane, 23 wherein said membrane is maintained around the remaining 24 nucleus; 25
Consolidated Interferences 105,504 and 105,505 Decision of Motions 4 c) stabilizing said membrane with said nucleus 1 remaining therein to give a product; and 2 d) admixing the product of step c) in a suspension 3 medium suitable for delivering said product of step c to a 4 hematology analyzer for analysis. 5 The claims of the parties are: 6 7 Ryan: 1-20 8 Young: 41-54, 60-73 and 86-87 9 10 The claims of the parties that correspond to Count 1 are: 11 12 Ryan: 1-20 13 Young: 41-54, 60-73 and 86-87 14 15 The claims of the parties that do not correspond to Count 1 are: 16 17 Ryan: None 18 Young: None 19 20 The parties have been accorded the following earlier constructive 21 reductions to practice (i.e., benefit for the purpose priority) for Count 1: 22 23 Ryan: None 24 Young: Application 10/214,717, filed 09 August 2002 25 26 Application 08/787,408, filed 22 January 1997, 27 now U.S. Patent 6,509,192, issued 21 January 2003. 28 29 Application 08/432,435, filed 28 April 1995. 30 31
Consolidated Interferences 105,504 and 105,505 Decision of Motions 5 Young is Senior Party based on its accorded priority date of 28 April 1 1995, which is over five years prior to Ryan's earliest date which is 2 03 December 2001. 3 Interference 105,505—Method using a control 4 Interference 105,505 was declared on 22 September 2006 5 (Int. 105,505, Paper 1). 6 The interference is between: 7 (1) Junior Party Wayne L. Ryan, based on U.S. Patent 8 6,653,137 B2, issued 25 November 2003 [second Ryan 9 patent], based on application 10/007,519, filed 10 03 December 2001 [second Ryan application], and 11 (2) Senior Party (a) Carole J. Young, (b) Michael N. Elliott, 12 (c) Nancy R. Naylor-Schlipp and (d) Timothy J. Fischer, 13 based on application 10/909,594, filed 02 August 2004 14 [second involved Young application]. 15 The real party in interest for Ryan is Streck Laboratories, Inc. 16 The real party in interest for Young is Beckman Coulter, Inc. 17 Interference 105,505 has been consolidated with Interference 105,504 18 (Paper 20). 19 Initially, Interference 105,505 was declared with Count 1 20 (Int. 105,505, page 7). 21 Young Substantive Motion 2 (Paper 33) has been granted (Paper 38). 22 As a result, Young claims 40, 42, 45, 58, 61, 65 and 68 containing improper 23 Markush language "selected from the group comprising" were cancelled and 24
Consolidated Interferences 105,504 and 105,505 Decision of Motions 6 Young claims 69-75 containing correct Markush language "selected from 1 the group consisting of" were added. 2 As a result of the motion being granted, the interference was 3 redeclared (Paper 39) to substitute original Count 1 with current Count 2. 4 Count 2 is the only count (Paper 39): 5 A method according to (1) any of claims 1, 5, 9 or 13 of Ryan 6 U.S. patent 6,653,137 B2 or (2) any of claims 43, 49, 51, 54, 7 59-60, 62-64, 67, 69 or 72-75 of Young application 10/909,594. 8 The claims of the parties are: 9 Ryan: 1-14 10 Young: 43, 49, 51, 54, 59-60, 62-64, 67 and 69-75 11 The claims of the parties which are designated as corresponding to 12 Count 2 are: 13 Ryan: 1-14 14 Young: 43, 49, 51, 54, 59-60, 62-64, 67 and 69-75 15 The claims of the parties which are designated as not corresponding 16 to Count 2 are: 17 Ryan: None 18 Young: None 19 Ryan claim 1 20 as corrected by a Certificate of Correction 21 issued 14 September 2004 22 23 A method of using a control including a nucleated red 24 blood cell component comprising the steps of: 25 a) providing a control including a stabilized blood cell 26 suitable for simulating a nucleated red blood cell, the stabilized 27 blood cell including a membrane enclosing a nucleus and 28
Consolidated Interferences 105,504 and 105,505 Decision of Motions 7 wherein the cytoplasm of the stabilized blood cell has been 1 substantially removed from within said membrane; 2 b) providing a hematology analyzer for analyzing a 3 blood cell sample by at least to angles of light scatter 4 measurement to differentiate nucleated red blood cells from 5 other cell types; 6 c) passing the control through the hematology analyzer 7 for detection of the simulated nucleated red blood cells; and 8 d) reporting nucleated red blood cells in said control. 9 10 Young claim 69 [replacing Young claim 40] 11 A method of using a hematology control product 12 including at least one nucleated blood cell analog comprising 13 the steps of: 14 a) providing a hematology control product including a 15 nucleated blood cell analog, wherein the analog is a blood cell 16 including a membrane enclosing a nucleus and hemoglobin, 17 wherein the blood cell has been treated so that said membrane 18 is resistant to degradation, and wherein 20% to 80% by weight 19 of the hemoglobin in the blood cell has been removed; 20 b) providing an instrument for analyzing a blood cell 21 sample by at least two physical properties selected from the 22 group consisting of DC volume, RF size, opacity, and light 23 scatter; 24 c) passing the control product through the instrument for 25 detection of said nucleated blood cell analog; and 26
Consolidated Interferences 105,504 and 105,505 Decision of Motions 8 d) reporting said nucleated blood cell analog in the 1 control product. 2 3 The parties have been accorded the following earlier constructive 4 reductions to practice (i.e., benefit for the purpose of priority) for Count 2: 5 6 Ryan: None 7 Young: Application 10/214,717, filed 09 August 2002 8 9 Application 08/787,408, filed 22 January 1997, 10 now U.S. Patent 6,509,192, issued 21 January 2003. 11 12 Application 08/432,435, filed 28 April 1995. 13 14 Young is Senior Party based on its accorded priority date of 28 April 15 1995, which is over five years prior to Ryan's earliest date which is 03 16 December 2001. 17 Motions 18 Substantive, responsive and miscellaneous motions have been 19 presented for our consideration. 20 Ryan Motion 1 21 Ryan Motion 1 (Paper 32) seeks entry of a judgment against Young 22 based on an alleged failure of Young to comply with the written description 23 and enablement requirements of 35 U.S.C. § 112. Young timely opposed 24 (Paper 56). Ryan timely replied (Paper 69). 25 Ryan Motion 2 26 Ryan Motion 2 (Paper 35) seeks entry of judgment against Young 27 based on an alleged failure of Young to comply with the provisions of 28
Consolidated Interferences 105,504 and 105,505 Decision of Motions 9 35 U.S.C. § 135(b)(2). Young timely opposed (Paper 57). Ryan timely 1 replied (Paper 70). 2 Ryan Miscellaneous Motion 4 3 Ryan Miscellaneous Motion 4 (Paper 81) seeks to exclude from 4 evidence Exhibits: 5 1033, 6 1036, 7 1039, 8 1051, 9 1073 and 10 1093 11 12 all filed by Young. Young timely opposed (Paper 89). Ryan timely replied 13 (Paper 91). 14 Young Motion 1 15 Young Motion 1 (Paper 53) seeks entry of a judgment against Ryan 16 based on alleged unpatentability under 35 U.S.C. § 103 over the prior art. 17 Ryan timely opposed (Paper 58). Young timely replied (Paper 67). 18 Young Responsive Motion 3 19 Young Responsive Motion 3 (Paper 36) is a responsive motion to 20 Ryan Motion 1. Proposed Young claim 88 would be added to involved 21 Young application 10/909,561. Proposed Young claim 76 would be added 22 to involved Young application 10/909,594. Ryan timely opposed (Paper 23 59), maintaining that the motion should not be granted because proposed 24 claims 88 and 76 do not comply with (1) the written description and 25 enablement requirements of 35 U.S.C. § 112 and (2) the provisions of 26 35 U.S.C. § 135(b)(2). Young timely replied (Paper 68). 27
Consolidated Interferences 105,504 and 105,505 Decision of Motions 10 Young Miscellaneous Motion 4 1 Young Miscellaneous Motion 4 (Paper 77) seeks entry of an order 2 striking Ryan reply 1 (Paper 69). According to Young, the reply for the first 3 time attacks Young's claims as being unpatentable under 35 U.S.C. § 102(b). 4 Ryan timely opposed (Paper 79). Young timely replied (Paper 84). 5 Young Miscellaneous Motion 5 6 Young Miscellaneous Motion 5 (Paper 85) seeks to exclude from 7 evidence Exhibits: 8 2060 (¶¶62-63), 9 2063, 10 2070 through 2077, 11 2083, 12 2107 (¶¶ 4-5, 24-30, 38-40), and 13 2109 14 15 all filed by Ryan. Ryan timely opposed (Paper 88). Young timely replied 16 (Paper 90). 17 B. Interference motion practice 18 At oral argument, counsel for both parties in arguing one motion made 19 reference to the record in another motion. 20 We take this opportunity to discuss two important facets of motions 21 practice before the Board in interference cases. 22 (1) 23 All evidence in an interference is presented to the Board in the form 24 of an exhibit. 25 When is an exhibit "in evidence" before the Board? 26 A first condition for an exhibit to be considered "in evidence" before 27 the board is that the exhibit must be filed. All exhibits are normally filed in 28
Consolidated Interferences 105,504 and 105,505 Decision of Motions 11 the motions phase at Time Period 8 and in the priority phase at Time Period 1 18. On relatively rare occasions, the Board may require an exhibit to be 2 filed earlier. 3 During an interference, a party may use an exhibit (e.g., in a cross- 4 examination deposition of an opponent’s witness) and ultimately decide not 5 to rely on the exhibit. Under this circumstance, the exhibit is neither filed 6 nor discussed in an opposition. The exhibit would not be in evidence. 7 Nevertheless, the opponent could list and rely on the exhibit in a reply, in 8 which case the exhibit would be submitted by opponent when exhibits are 9 filed... 10 A second condition is that the exhibit must be listed and discussed in a 11 motion, opposition or reply. 12 If a miscellaneous motion to exclude an exhibit is granted, the exhibit 13 is not in evidence and will not be considered. 14 Moreover, an exhibit is considered "in evidence" only to the extent 15 that the exhibit or a portion of the exhibit is mentioned and relied upon in a 16 motion, opposition or reply. A party cannot list and rely on an exhibit for 17 one purpose in the motions and sometime later in the proceeding, e.g., 18 during the priority phase, rely on the exhibit for another purpose unless the 19 motion is again listed and relied upon for the other purpose in a motion for 20 judgment based on priority. 21 (2) 22 A procedural requirement for properly filing a motion, opposition or 23 reply is that the motion, opposition or reply list the evidence relied upon in 24 the motion, opposition or reply. 25
Consolidated Interferences 105,504 and 105,505 Decision of Motions 12 Each motion is considered on its own merits solely on the basis of the 1 evidence relied upon in support of the motion, opposition or reply. 2 An exhibit listed and relied upon in a first motion, e.g., motion 1, 3 cannot be relied upon in a second motion, e.g., motion 2, unless the exhibit 4 is also listed and discussed in motion 2. 5 Admission of evidence before the Board differs from trial practice in 6 Federal Court where generally once an exhibit is admitted in evidence, the 7 exhibit can be relied upon in support of or in opposition to any issue. 8 In an interference with multiple motions, each motion should be 9 viewed as a separate proceeding independent of other motions at least for the 10 purpose of determining what evidence will be considered in resolving a 11 given motion. 12 Board practice allows the Board to allocate resources by assigning one 13 panel judge to one motion and another panel judge to another motion. 14 Cf. Interference 105,402 where an opinion resolving one set of motions was 15 authored by one judge (Int. 105,402, Paper 114) and an opinion resolving 16 a different set of motions was authored by another judge (Int. 105,402, 17 Paper 115). Cf. Joy Technologies, Inc. v. Quigg, 12 USPQ2d 1112 (D.D.C. 18 1989) (Judge Gasch decided question of whether jury trial available in civil 19 action under 35 U.S.C. § 145) and Joy Technologies, Inc. v. Manbeck, 20 17 USPQ2d 1257 (D.D.C. 1990) (Judge Bennett decided patentability on the 21 merits). 22 Another administrative advantage of Board practice is that it 23 minimizes the chance that an opponent will be surprised or blindsided or that 24 the Board will inadvertently consider an exhibit listed in one motion when 25
Consolidated Interferences 105,504 and 105,505 Decision of Motions 13 deciding another motion—reliance on evidence not relied upon by a party 1 can be prejudicial to an opponent. 2 3 C. Background of technology 4 Blood cells 5 Blood is a suspension of small, highly concentrated cells in plasma. 6 Paper 32, page 3; Ex 2003, ¶ 9. 7 Blood includes white blood cells and red blood cells. 8 Red blood cells are known as "erythrocytes." 9 White blood cells are known as "leukocytes." 10 Red blood cells are smaller than white blood cells, but red blood cells 11 outnumber white blood cells in the neighborhood of 1000 red blood cells for 12 each white blood cell. 13 For the most part, human and other mammal red blood cells do not 14 have a nucleus, but are rich in hemoglobin. Ex 2003, ¶ 10. 15 However, human red blood cells from umbilical cords can be 16 nucleated. Ex 2003, ¶ 11; Ex 2048, ¶ 2; Ex 2006, (nucleated red blood cell 17 shown in blue). 18 The presence of nucleated red blood cells in adult human blood 19 indicates "a serious medical concern." Ex 2003, ¶ 11. Paper 108 [transcript 20 of first oral argument], page 5:25 through page 6:4. 21 Some non-mammal animals have red blood cells with a nucleus and 22 the cells can be larger than human red cells. Ex 2003, ¶ 12. 23 The non-mammal animals include fish, amphibians, reptiles and birds, 24 whose red blood cells are larger than mammalian red blood cells. 25 Ex 2003, ¶ 12; Ex 2007. 26
Consolidated Interferences 105,504 and 105,505 Decision of Motions 14 White blood cells contain a nucleus and cytoplasm, but no 1 hemoglobin. Ex 2003, ¶ 13. 2 Hematology 3 Hematology is the study of the nature, function and diseases of the 4 blood. Ex 2003, ¶ 14. 5 Instruments used to analyze blood are known as hematology 6 analyzers. Ex 2003, ¶ 14. 7 One function of a hematology analyzer is to count the various blood 8 cells, i.e., how many red cells and how many white cells are present in a 9 given sample of blood. 10 To confirm the accuracy of measurements, it is necessary to have 11 quality control materials that simulate a blood specimen. 12 The controls may contain stabilized cells which serve as "analogs" for 13 various blood cells and are designed to simulate the measured characteristics 14 of blood components being analyzed. 15 In effect, a control is used in an analyzer to calibrate the analyzer and 16 ensure that the analyzer is working properly. 17 A control may have more than one analog. 18 Ryan provides the following "simplified flow diagram" of a 19 hematology analysis: 20 21
Consolidated Interferences 105,504 and 105,505 Decision of Motions 15 Whole blood (meaning a blood sample from a patient undergoing 1 examination) is delivered to a hematology analyzer. 2 The sample is split into parallel channels A and B. 3 In channel A, whole blood is analyzed in order to count the red blood 4 cells. 5 The presence of white cells in channel A generally does not impact 6 the enumeration of red blood cells because any white cells are greatly 7 outnumbered by red blood cells. 8 While there may be some disagreement on whether lysing of red 9 blood cells is necessary (see, e.g., Ex 2003, ¶ 46 versus Ex 1041, ¶ 100), it 10 appears generally that whole blood in channel B is treated with a lysing 11 agent in order to "burst" the red blood cells (i.e., destroy the red cell 12 structure) so that any red cells do not interference with the enumeration of 13 white blood cells. White blood cells can then be counted. 14 D. Level of skill in the art 15 The parties presented evidence on the level of skill in the art. 16 Ryan witness Dr. Warren Groner (see, e.g., Ex 2003) and Young 17 witness Dr. James L. Wyatt (see, e.g., Ex 1041) testified on the level of skill 18 in the art. 19 Dr. Wyatt testified on direct about the level of skill in the art (see, 20 e.g., Ex 1041, page 32, ¶ 222 through page 37, ¶ 260). 21 Dr. Groner has also testified, mostly on cross-examination (see, e.g., 22 Ex 1040, page 15:1 through page 16:17), about the level of skill in the art. 23 In resolving any factual issue concerning the level of skill in the art, 24 we do, and need not, decide whether Dr. Wyatt or Dr. Groner is a person 25
Consolidated Interferences 105,504 and 105,505 Decision of Motions 16 having ordinarily skill in the art. Rather, we look to see what both tell us 1 about what the hypothetical person of skill in the art would know. 2 According to Dr. Wyatt, the level of skill at the relevant time was 3 "high." 4 While a "high" skill level per se does not tell us much, what Dr. Wyatt 5 means by "high" is that a person of ordinary skill in the art of designing and 6 developing hematology controls would have an advanced degree, meaning 7 either a Masters degree or a Ph.D is a bioscience. Ex 1041, ¶¶ 222-224. See 8 also Ex 1040, page 15:17:24 and page 111:23 through 112:4. 9 Educational degrees in and of themselves often do not tell us much. 10 Argyropoulos v. Swarup, 56 USPQ2d 1795, 1807 (Bd. Pat. App. & Int. 11 2000) (explaining why defining the level of skill in the art in terms of 12 degrees obtained is less helpful than defining it in terms of what such a 13 person would have known and what the person would have been able to do). 14 However, Dr. Wyatt follows up with why having an advanced degree 15 (i.e., a degree beyond a Bachelor's degree) is significant. 16 A person with a Masters degree has completed some type of 17 laboratory project that a person with a Bachelor's degree has not. 18 Ex 1041, ¶ 225. 19 The person with an advanced degree would (1) have a broader 20 perspective of the cell properties that are subject to manipulation and 21 analysis and (2) be more knowledgeable about the nuances of cell 22 manipulation techniques. Ex 1041, ¶ 226. 23
Consolidated Interferences 105,504 and 105,505 Decision of Motions 17 A person having ordinary skill in this art would have had experience 1 in development of controls for use in commercial analyzers. Ex 1041, ¶ 230. 2 See also Ex 1040, page 16:7-11. 3 The person would have had experience in cell handling and in cell 4 biology, as well as an understanding of biology in general. Ex 1041, ¶ 229. 5 The person would not have been a mere technician following the 6 instructions of others for making and using controls. Ex 1041, ¶ 232. In 7 other words, to quote KSR International Co. v. Teleflex, Inc., 127 S. Ct. 8 1727, 1742 (2007), the person would not be an "automaton". 9 The person would have had experience in testing controls in 10 hematology analyzers. Ex 1041, ¶ 233. See also Ex 1040, page 16:12-17 11 (Dr. Groner agreed the person would have had experience directed to 12 designing and preparing commercial controlled preparations for blood 13 analyzers). 14 Significantly, in Dr. Wyatt's opinion, the person following a known 15 method of making a control, would be expected to run it through a 16 hematology analyzer to see what results are obtained and to make any 17 adjustments necessary to the method. Ex 1041, ¶ 235. 18 The person would have an understanding of the biology of any 19 sources cells, including which have nuclei and which do not, and of 20 techniques for adjusting cells. Ex 1041, ¶ 239. 21 The person would have been able to direct or conduct the process of 22 manipulating by laboratory processes the properties of a source cell so that 23 it mimicked a target cell to provide the same response in a given analyzer. 24 Ex 1041, ¶ 240. 25
Consolidated Interferences 105,504 and 105,505 Decision of Motions 18 The person would understand that a hematology analyzer would be 1 used to analyze whole blood, including white cells, platelets and red cells. 2 Ex 1041, ¶ 246. 3 The person would be aware of the different types of signals used in 4 analyzers, how those signals indicate the presence of various types of cells, 5 and would understand that analyzers could detect a target blood cell using 6 one or more tools, such as DC volume, RF impedance and light scatter at 7 various angles of measurement. Ex 1041, ¶¶ 247-248. 8 Dr. Wyatt goes on to state other qualifications the person of ordinary 9 skill would possess. Ex 1041, ¶¶ 249-260. 10 Our impression is that a person of ordinary skill in the art, in addition 11 to what the prior art in the case reveals, knows quite a bit about blood, 12 testing blood samples, using analyzers and making controls. 13 E. Ryan Motion 2 14 Pursuant to 37 C.F.R. § 41.125(a) (2007), we exercise discretion to 15 consider first Ryan Motion 2. See also Berman v. Housey, 291 F.3d 1345, 16 1351 (Fed. Cir. 2002). 17 Ryan Motion 2 seeks judgment against Young based on Young's 18 alleged failure to comply with 35 U.S.C. § 135(b) (2). 19 Findings of fact 20 Ryan applications and patents 21 Involved Ryan patent 6,723,563 B2 issued 20 April 2004 (first Ryan 22 patent) based on application 10/005,999 filed 03 December 2001 (first 23 Ryan application). Ex 1001. 24
Consolidated Interferences 105,504 and 105,505
Decision of Motions
19
The first Ryan application was published as U.S. Patent Application 1
Publication 2003/0104630 A1 on 05 June 2003. Ex 2017. 2
Involved Ryan patent 6,653,137 B2 issued 25 November 2003 3
(second Ryan patent) based on application 10/007,519, filed 03 December 4
2001 (second Ryan application). Ex 1002. 5
The second Ryan application was published as U.S. Patent 6
Application Publication 2003/0104629 A1 on 05 June 2003. Ex 2016. 7
Young applications 8
Young filed Young application 10/214,717 on 09 August 2002 (first 9
Young application). Ex 1069, page 1. 10
On 08 October 2004, Young filed an amendment ("Supplemental 11
Amendment") in which numerous "new" claims were presented. Ex 1069. 12
One of those new claims was Young claim 81 (Ex 1069, page 21): 13
A method of making a control including a nucleated 14
blood cell component comprising the steps of: 15
a) providing a blood cell suitable for simulating a 16
nucleated blood cell, said blood cell including a membrane 17
enclosing nucleus and cytoplasm; 18
b) removing cytoplasm from within said membrane, 19
wherein said membrane is maintained around the remaining 20
nucleus; 21
c) stabilizing said membrane with said nucleus 22
remaining therein to give a product; and 23Consolidated Interferences 105,504 and 105,505
Decision of Motions
20
d) admixing the product of step c) in a suspension 1
medium suitable for delivering said product of step c to a 2
hematology analyzer for analysis. 3
As is apparent, Young claim 81 presented in the first Young 4
application is the same as involved Young claim 41. 5
The Examiner (1) determined that certain Young claims (including 6
Young claim 81) were directed to an invention which was independent and 7
distinct (35 U.S.C. § 121) from the invention then being claimed by Young 8
and (2) required restriction. Ex 1072, page 2, ¶ 1 (a restriction requirement 9
was entered on 28 December 2004; this fact is not apparent from Ex 1072, 10
but we take official notice based on PTO records that the restriction was 11
entered on 28 December 2004). 12
As a result of the Examiner's requirement for restriction, Young 13
elected to prosecute the invention of claim 81 in involved Young application 14
10/909,561, which previously had been filed on 02 August 2004. Ex 1003. 15
Involved Young application 10/909,561 is characterized as a 16
"continuation" of the first Young application. Ex 1003, page 1. 17
Involved Young claim 41 was presented in the involved Young 18
application as filed. 19
As noted earlier, Young filed the first Young application on 20
09 August 2002. Ex 1069, page 1. 21
On 08 October 2004, Young filed an amendment ("Supplemental 22
Amendment") in which numerous "new" claims were presented. Ex 1069. 23
One of those new claims was Young claim 52 (Ex 1069, pages 9-10) 24
[italics added]: 25Consolidated Interferences 105,504 and 105,505 Decision of Motions 21 A method of using a hematology control product 1 including at least one nucleated blood cell analog comprising 2 the steps of: 3 a) providing a hematology control product including a 4 nucleated blood cell analog, wherein the analog is a blood cell 5 including a membrane enclosing a nucleus and hemoglobin, 6 wherein the blood cell has been treated so that said membrane 7 is resistant to degradation, and wherein 20% to 80% by weight 8 of the hemoglobin in the blood cell has been removed; 9 b) providing an instrument for analyzing a blood cell 10 sample by at least two physical properties selected from the 11 group comprising DC volume, RF size, opacity, and light 12 scatter; 13 c) passing the control product through the instrument for 14 detection of said nucleated blood cell analog; and 15 d) reporting said nucleated blood cell analog in the 16 control product. 17 Young claim 52 presented in the first Young application is the same 18 as involved Young claim 69 with one exception: "consisting of" has 19 replaced "comprising" by virtue of the granting of Young miscellaneous 20 motion 2. The difference is not a substantive difference; rather, it merely 21 corrects improper Markush language. 22 The Examiner (1) determined that certain Young claims (including 23 claim 52) were directed to an invention which was independent and distinct 24
Consolidated Interferences 105,504 and 105,505 Decision of Motions 22 (35 U.S.C. § 121) from the invention then being claimed in the first Young 1 application and (2) required restriction. Ex 1072, page 2, ¶ 1. 2 As a result of the Examiner's requirement for restriction, Young 3 elected to prosecute the invention of claim 52 in the involved Young 4 application 10/909,594, which previously had been filed on 02 August 2004. 5 Ex 1004. 6 Involved Young application 10/909,594 is characterized as a 7 "continuation" of the first Young application. Ex 1003, page 1. 8 What was Young claim 52 in the first Young application became 9 Young claim 40 of the involved Young application, as filed. 10 As noted earlier, Young claim 40 has been cancelled and has been 11 replaced with Young claim 69. 12
Consolidated Interferences 105,504 and 105,505 Decision of Motions 23 A chronological summary of events follows: 1 1. 12-03-2001 First Ryan application filed 2 12-03-2001 Second Ryan application filed 3 4 2. 08-09-2002 First Young application 10/214,717 filed 5 6 3. 06-05-2003 First Ryan application published 7 06-05-2003 Second Ryan application published 8 9 4. 11-25-2003 Second Ryan patent issued 10 11 5. 04-20-2004 First Ryan patent issued 12 13 6. 08-02-2004 Involved Young application 10/909,561 filed 14 08-02-2004 Involved Young application 10/909,594 filed 15 16 7. 10-08-2004 Claims presented in first Young application 17 18 8. 12-28-2004 Restriction required in first Young application 19 20 Young maintains that 35 U.S.C. § 135(b) (2) does not apply, because 21 the first Young application was filed before the first and second Ryan 22 applications were published. 23 Ryan maintains that 35 U.S.C. § 135(b) (2) applies, because the 24 claims in the first Young application were presented more than one year 25 after the first and second Ryan application were published. 26 Section 135(b) (1) does not apply to this case, because the claims in 27 the involved Young applications were presented less than a year after the 28 first and second Ryan patents issued. 29
Consolidated Interferences 105,504 and 105,505 Decision of Motions 24 Analysis 1 Section 135(b) (2) reads: 2 A claim which is the same as, or for the same or substantially 3 the same subject matter as, a claim of an application published 4 under section 122(b) of this title may be made in an application 5 filed after the application is published only if the claim is made 6 before 1 year after the date on the application is published. 7 Young maintains that it should prevail for three reasons. 8 First, by virtue of 35 U.S.C. § 120, the involved Young claims are 9 entitled to the benefit of an earlier filing date, viz., 09 August 2002 which is 10 a date prior to the publication of the Ryan applications. 11 Second, the involved Young claims were presented in an application 12 filed prior to the publication of the Ryan applications. 13 Third, Ryan has failed to establish that the subject matter of the claims 14 in its published Ryan applications is not materially different from the subject 15 matter of the claims in the Ryan patents. 16 Young prevails if it is right on any one of its reasons. Ryan can 17 prevail only if Young is wrong on all three reasons. In our view, Young is 18 wrong in all respects regarding Interference 105,504 involving a method for 19 making a control. On the other hand in Interference 105,505, we agree with 20 Young that the claims of the second Ryan patent (6,653,137 B2) contain 21 material limitations vis-à-vis the claims published in second published Ryan 22 application (2003/0104629 A1). 23
Consolidated Interferences 105,504 and 105,505 Decision of Motions 25 Reason (1) 1 A. 2 Ryan maintains that the statutory language "in an application filed 3 after" precludes applying the provisions of 35 U.S.C. § 120 to that 4 application for the purpose of evaluating compliance with 35 U.S.C. 5 § 135(b) (2). We disagree. See Ding v. Singer, Interference 105,436, 6 Paper 36, pages 8-13) (Bd. Pat. App. & Int. 2007) (available at 7 https://acts.uspto.gov/ifiling/PublicView.jsp?identifier=105436&identifier2= 8 null&tabSel=4&action=filecontent&replyTo=PublicView.jsp followed by 9 inserting the interference number, clicking on file contents and clicking on 10 Document 56). 11 The first sentence of § 120 states in relevant part: 12 An application for patent for an invention disclosed in the 13 manner provided by the first paragraph of section 112 … in an 14 application previously filed in the United States … shall have 15 the same effect, as to such invention, as though filed on the date 16 of the prior application …. 17 18 The portions of § 120 dealing with same inventors and copendency have not 19 been quoted. The Young inventors are the same and there has been no 20 suggestion of a lack of copendency. 21 The starting point for interpreting a statute is the language of the 22 statute. United States v. Goodyear Tire and Rubber Co., 493 U.S. 132, 138 23 (1969); Kelly v. Robinson, 479 U.S. 36, 43(1986). Words in a statute will be 24 interpreted as having their ordinary, contemporary and common meanings. 25 Perrin v. United States, 444 U.S. 37, 42 (1979). Statutes relating to the 26
Consolidated Interferences 105,504 and 105,505 Decision of Motions 26 same thing ought to be taken into consideration in construing any one of 1 them, and it is a rule of law that all statutes in pari materia are to be taken 2 together, as if they were one law. United States v. Freeman, 3 How. 3 (44 U.S.) 556, 564 (1845). A reading of a statute that would lead to absurd 4 results is to be avoided when it can be given a reasonable application 5 consistent with its words. Haggar Co. v. Helvering, 308 U.S. 389, 394 6 (1940). 7 The in pari materia statutory construction canon trumps Ryan's 8 argument. Both § 120 and § 135(b)(2) use the word "application" and there 9 is no reason to believe that Congress intended to have "application" mean 10 one thing in § 135(b)(2) and something else in § 120 and thereby exclude the 11 earlier filing date benefits of § 120 to applications filed after an application 12 is published. 13 Nor would it make sense to restrict the applicability of § 120 in cases 14 involving § 135(b) (2). The facts of this case show why. Congress 15 authorized applicants to file applications. Congress further authorized the 16 Director to restrict applications to a single independent and distinct 17 invention. 35 U.S.C. § 121. Congress still further authorized the filing of a 18 different application to permit applicants to prosecute the invention 19 restricted out of their earlier application. 35 U.S.C. §§ 120, 121. Here the 20 Examiner made a restriction requirement in a Young application filed before 21 the Ryan applications were published. Although Young filed the involved 22 Young applications before the restriction requirement was made, Young 23 nevertheless had a right to take advantage of a congressional authorization to 24
Consolidated Interferences 105,504 and 105,505 Decision of Motions 27 file its continuing applications to pursue that which the Examiner would not 1 allow to be pursued in the first Young application. 2 Ryan says, in effect: "Too bad--the statute says nothing about § 120 3 and so it is not available." However, § 120 applies on its face. We will not 4 impute to Congress an intent to exclude the application of § 120 without 5 some clear legislative history. 6 Under Ryan's construction of § 135(b)(2), an applicant could exercise 7 a § 120 right to antedate § 102(b) prior art, but could not exercise a similar 8 opportunity to antedate a § 135(b)(2) bar based on an application filed 9 before publication where the vary claims in issue were presented. 10 Ryan makes reference to 35 U.S.C. § 154(a) (2) relating to patent 11 terms. Congress determined that if an applicant relies under § 120 on an 12 earlier application date, patent term is 20 years from the filing of the earlier 13 application and not the application which matured into a patent. The 14 reference to § 120 was necessary in § 154(a) (2) in order to accomplish a 15 congressional objective of eliminating "submarine" patents. No such 16 reference is necessary in § 135(b) (2). The language of § 120 permits an 17 applicant to rely on its provisions for all purposes during examination of a 18 patent application, including establishing an earlier date for avoiding both 19 § 102(b) bars and § 135(b) (2) bars. 20 B. 21 1. 22 To successfully claim benefit under 35 U.S.C. § 120, the involved 23 Young claims must be described in the first Young application in the manner 24 required by the first paragraph 35 U.S.C. § 112. As will become apparent 25
Consolidated Interferences 105,504 and 105,505
Decision of Motions
28
later in this opinion, we believe that the subject matter described in the first 1
Young application, in combination with the prior art, would have rendered 2
obvious the subject matter which Young now claims in the involved Young 3
applications. But, "obviousness" is not the test for complying with the 4
written description requirement. University of California v. Eli Lilly and 5
Co., 119 F.3d 1559, 1567-68 (Fed. Cir. 1997) ("Recently, we held that a 6
description which renders obvious a claimed invention is not sufficient to 7
satisfy the written description requirement of that invention."); Lockwood v. 8
American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997) ("The 9
question is not whether a claimed invention is an obvious variant of that 10
which is disclosed in the specification. Rather, a prior application itself 11
must describe an invention, and do so in sufficient detail that one skilled in 12
the art can clearly conclude that the inventor invented the claimed invention 13
as of the filing date sought."). 14
Federal Circuit precedent also tells us that when relying on an earlier 15
claim for the purpose of § 135(b)(1), the claim which was "timely" presented 16
must find support. University of California v. University of Iowa Research 17
Foundation, 455 F.3d 1371, 1376-77 (Fed. Cir. 2006). The same result 18
seemingly is appropriate under § 135(b)(2). 19
2. 20
Ryan maintains that the subject matter of the involved Young claims 21
is not described in the first Young application. Ryan acknowledges that the 22
first Young application contains extensive discussion of nucleated white 23
blood cells. Ryan maintains that there is no description of nucleated red 24
blood cells. Ryan reasons that Young does not describe a generic invention 25Consolidated Interferences 105,504 and 105,505 Decision of Motions 29 dealing with nucleated blood cells. Ryan offers the testimony of Dr. Warren 1 Groner in support of its position. Ex 2003 (direct); Ex 1040 (cross- 2 examination). 3 Young maintains that the first Young application contains a written 4 description of a method for making and using nucleated blood cells 5 generally (which would include nucleated red blood cells). Young has to 6 acknowledge, however, that the first Young application does not mention 7 explicitly a method for making or using a control analog of "nucleated blood 8 cells" generally or "nucleated red blood cells" in particular. Young 9 maintains, however, that the disclosure in the first Young application has 10 sufficient information to enable one skilled in the art to make and use 11 control analogs of "nucleated blood cells," including "nucleated red blood 12 cells." Young offers the testimony of Dr. James L. Wyatt in support of its 13 position. Ex 1041 (direct). Dr. Wyatt was not cross-examined. 14 3. 15 Dr. Groner and Dr. Wyatt have impressive credentials. Both appear to 16 be well-versed in the relevant art before us. While they agree on some 17 points, they disagree on other points. In making our credibility assessment 18 in this case we have considered not only the portions of the testimony cited 19 throughout this opinion, but the testimony as a whole, including relevant 20 cross-examination. As will become apparent, we find that Dr. Groner 21 focuses on description (a finding of fact) in the first Young application in a 22 way we find highly credible. Dr. Wyatt, on the other hand, focuses on 23 enablement (a legal issue) of the involved Young applications in a way 24 which we find highly credible. 25
Consolidated Interferences 105,504 and 105,505 Decision of Motions 30 In this case, the description issue is the controlling issue on the 1 question of benefit under 35 U.S.C. § 120. For these reasons, as well as an 2 overall assessment of the respective testimony of both witnesses, and to the 3 extent there is a conflict between the testimony of Dr. Groner and that of 4 Dr. Wyatt on the issue of written description of the first and second Young 5 applications, we credit the testimony of Dr. Groner over that of Dr. Wyatt. 6 On the other hand, on the issue of enablement of the involved Young 7 applications (discussed in Part F), we credit the testimony of Dr. Wyatt over 8 than of Dr. Groner. 9 4. 10 One significant fact is that, as filed, the first Young application did not 11 have an original claim to a "nucleated blood cell." Because the original 12 claims in the involved Young application claimed a "nucleated blood cell" 13 and since original claims form part of the disclosure of an application, it 14 becomes apparent that the original disclosure of the first Young application 15 is not exactly the same as the original disclosure of the involved Young 16 application. 17 The difference alone, however, does not mean that "nucleated blood 18 cells" are not described in the first Young application. Rather, we determine 19 whether "nucleated blood cells" are described in the first Young application 20 based on the actual description in the first Young application (the best 21 evidence of what is described therein) and the testimony by Dr. Groner and 22 Dr. Wyatt as to what one skilled in the art would have understood from the 23 first Young application. 24
Consolidated Interferences 105,504 and 105,505 Decision of Motions 31 The governing principles are set out in In re Alton, 76 F.3d 1168 (Fed. 1 Cir. 1996) ((1) 1171: The issue of whether a patent specification adequately 2 describes the subject matter claimed in a question of fact; (2) 1172: The 3 adequate written description requirement, which is distinct from the 4 enablement and best mode requirements, serves to ensure that the inventor 5 had possession, as of the filing date of the application relied on, of the 6 specific subject matter later claimed by him; how the specification 7 accomplishes this is not material. In order to meet the adequate written 8 description requirement, the applicant does not have to utilize any particular 9 form of disclosure to describe the subject matter claimed, but the description 10 must clearly allow persons of ordinary skill in the art to recognize that [he or 11 she] invented what is claimed. The applicant must convey with reasonable 12 clarity to those skilled in the art that, as of the filing date sought, he or she 13 was in possession of the invention. Precisely how close the original 14 description must come to comply with the description requirement of section 15 112 must be determined on a case-by-case basis. (3) 1174: Evidence 16 addressing written description factual issue is properly considered.) . 17 5. 18 Dr. Groner acknowledges that the term "nucleated blood cell" is 19 generic to white blood cells (which contain a nucleus) and nucleated red 20 blood cells. Ex 2003, pages 8-9, ¶ 20. 21 The first Young applications, however, never mention a method for 22 making or using a control analog for nucleated red blood cell. Ex 2003, 23 page 8, ¶ 21. 24
Consolidated Interferences 105,504 and 105,505 Decision of Motions 32 Nor beyond discussing white blood cells, does the first Young 1 application mention a method for making or using a control analog for 2 nucleated blood cells. Ex 2003, page 8, ¶ 22. 3 The first Young application focuses on making analogs for named 4 white blood cells. Ex 2003, page 8, ¶ 23. 5 We agree with Dr. Groner, and therefore find, that the first Young 6 application would not have reasonably conveyed, to one skilled in the 7 relevant art of hematology analyzers and controls, that Young had invented a 8 method of making or using an analog for a generic class of "nucleated blood 9 cell's or a method of making or using an analog for a nucleated red blood 10 cell. Ex 2003, page 8, ¶ 24. 11 Dr. Groner takes us through the first Young application, pointing out 12 precisely what can be found in the application. 13 Starting with the summary of the invention (Ex 1003, numbered 14 page 12—note that the first two pages of Ex 1003 are not page numbered), 15 Dr. Groner notes, and we agree, that summary discusses a method for 16 making and using an analog for a white blood cell. Ex 2003, pages 8-10, 17 ¶ 25. 18 No nucleated red blood cell is mentioned in the summary. 19 No reference to nucleated blood cells is mentioned in the summary. 20 A (1) leukocyte analog (Ex 1003, page 13:1), (2) leukocyte analog 21 population (Ex 1003, page 13:15-16), and (3) leukocyte subpopulation 22 (Ex 1003, page 14:4-5) are mentioned. All involve white blood cells. 23 Dr. Groner discusses the detailed description of the invention section 24 of the first Young application (Ex 1003, pages 14-69). 25
Consolidated Interferences 105,504 and 105,505 Decision of Motions 33 No method for making or using a nucleated red blood cell analog is 1 mentioned in the detailed description of the invention. 2 What is mentioned, as Dr. Groner correctly points out, are multiple 3 references to analogs for white blood cells, some of which are made from 4 non-human nucleated red blood cells. Ex 2003, page 10-11, ¶ 26. 5 One reference is to current multiple white blood cell population 6 analysis. Ex 1003, page 20:20. 7 Another reference is what Dr. Groner refers to as a general method 8 for making leukocyte analogs. Ex 1003, page 21:21 and Ex 2003, 9 page 11:2-16. 10 The first Young application teaches that the process also enables the 11 swelling of red blood cells greater than 50% of their original volume which 12 is said to provide a wider latitude in the selection of animal cells for 13 producing the desired analogs—which we note are white blood cells 14 analogs. Ex 1003, page 22:7-12. 15 The first Young application also teaches that the cells of birds, 16 alligators and nurse sharks are nucleated, but the presence of a nucleus is 17 neither essential nor detrimental for their use as a substitute for human white 18 blood cells, given the process described in the application which is said to 19 permit a regulated hemolysis of the red blood cell. Ex 1003, page 23:3-8. 20 Dr. Groner discusses Young's "preferred process" which embodies a 21 composition prepared by mixing a suspension of fixed goose red blood cells 22 to simulate human lymphocytes (white blood cells) or fixed alligator red 23 blood cells to simulate human monocytes, neutrophils, and eosinophils (all 24 white blood cells). Ex 2003, pages 11-12; Ex 1003, page 23:24-31. 25
Consolidated Interferences 105,504 and 105,505 Decision of Motions 34 As recognized by Dr. Groner, the first Young application contains six 1 examples. Ex 2003, page 12, ¶ 29. 2 Example 1 (Ex 1003, page 55) describes a method for preparing an 3 analog for a lymphocyte (which Dr. Groner characterizes as a white blood 4 cell subpopulation) involving the step of treating goose red blood cells to 5 make an analog that is said to simulate human lymphocyte cells in normal 6 human blood. Ex 2003, page 13, ¶ 30. 7 Example 2 (Ex 1003, page 58) describes a method for preparing an 8 analog for a monocyte (which Dr. Groner characterizes as another white 9 blood cell subpopulation) involving treating alligator red cells to make an 10 analog that is said to simulate human monocyte cells in normal human 11 blood. Ex 2003, pages 13-14, ¶ 31. 12 Example 3 (Ex 1003, page 60) describes a method for making an 13 analog for eosinophil (which Dr. Groner characterizes as another white 14 blood cell subpopulation) involving treating alligator red blood cells to make 15 an analog that simulates human eosinophil cells in normal human blood. 16 Ex 2003, page 14, ¶ 32. 17 Example 4 (Ex 1003, page 62) describes a method for making an 18 analog for neutrophil (which Dr. Groner characterizes as another white 19 blood cell subpopulation) involving treating an alligator red blood cell to 20 make an analog that simulates a human neutrophil cell in normal human 21 blood. Ex 2003, page 14, ¶ 33. 22 Example 5 (Ex 1003, page 64) describes "fixing" white blood cells 23 from human blood to simulate human leukocyte cells in normal human 24 blood. Ex 2003, page 14, ¶ 34. 25
Consolidated Interferences 105,504 and 105,505 Decision of Motions 35 Example 6 (Ex 1003, page 66) describes a sub-assembly for 1 simulating white blood cells in normal human blood; the sub-assembly is 2 made by combining the analogs prepared by Examples 1-4 with various 3 components to simulate human blood. Ex 2003, page 15, ¶ 35. 4 Based on the specification of the first Young application, as a whole, 5 we agree with Dr. Groner that one skilled in the art reading the first Young 6 application would have come to the conclusion that Young's invention was 7 directed solely to methods for making and using a control containing an 8 analog for a white blood cell or white blood cell subpopulations. Ex 2003, 9 pages 17-18, ¶ 38. 10 We also agree with Dr. Groner's conclusion, based on the first Young 11 specification, as a whole, that one skilled in the art would not have found 12 that Young had possession of a method for making or using a control for 13 nucleated red blood cells or "nucleated blood cells" in general apart from 14 white blood cells. Ex 2003, page 18, ¶ 39. 15 6. 16 Dr. Wyatt testified that a person of ordinary skill in the art would have 17 thought of nucleated red blood cells (NRBCs) and white blood cells (WBCs) 18 as a common genus because their detection by hematology analyzers often 19 overlapped. Ex 1041, page 21, ¶ 159. 20 According to Dr. Wyatt (Ex 1041, page 23, ¶ 168): 21 The [first] Young specification also specifically discusses how 22 to make fixed red blood cells, described several times as stable 23 or resistant to lysing … as well as unfixed red blood cells that 24 will lyse. 25
Consolidated Interferences 105,504 and 105,505 Decision of Motions 36 In support of his position, Dr. Wyatt refers to various portions of the 1 first Young application. 2 A first reference is to page 23:14-18: 3 Another process for the manufacture of the leukocyte analogs 4 that are useful in the method of this invention includes the 5 stabilizing of human white blood cells to simulate at least one 6 of the five subpopulations of leukocytes. 7 Dr. Wyatt fails to explain how the first reference describes making or 8 using an analog for a nucleated red blood cell; the reference is facially 9 limited to white blood cells. 10 A second reference is to page 28:9-14: 11 Fixing of the swollen cells is important to toughen the cells 12 membranes and to prevent degradation of the membranes. This 13 is accomplished by contacting the cells with a solution of 14 organic aldehyde, including monoaldehyes such as 15 formaldehyde, or dialdehydes such as glutaraldehyde. 16 Dr. Wyatt fails to explain how the second reference makes reference 17 to nucleated blood cells in general or nucleated red blood cells in particular. 18 A third reference is to page 38:12-15: 19 As appreciated by one skilled in the art, the suspension media 20 should have sufficient tonicity to avoid cell lysis. 21 Dr. Wyatt does not tell us how the third reference is a description of a 22 method for making or using an analog for nucleated red blood cells in 23 general or nucleated red blood cells in particular. 24 A fourth reference is to page 29:20-23: 25
Consolidated Interferences 105,504 and 105,505 Decision of Motions 37 In addition, the pH affects the release of hemoglobin. If the 1 fixation reaction occurs too quickly, the cell will not be able to 2 leak the hemoglobin. 3 In some instances, analogs are made from red blood cells. See, e.g., 4 Examples 1 and 2 and the discussion at Ex 1003, page 23:3-8: 5 the cells of avian [sic—birds], alligators and nurse sharks, are 6 nucleated, but the presence of a nucleus is neither essential nor 7 detrimental for their use as a substitute for human white blood 8 cells, given the process described herein which permits a 9 regulated hemolysis of the red blood cells. 10 Dr. Wyatt has not explained why the fourth reference is not a 11 reference to how hemoglobin is removed from nucleated red blood cells 12 used to make control analogs for white blood cells. Nowhere does 13 Dr. Wyatt explain how the fourth reference is a description associated with 14 making or using a control analog for nucleated red blood cells. 15 A fifth reference is to page 36:1-5 (Ex 1041, page 23, ¶ 168, last two 16 lines), although we think the reference should probably be to page 35:27 17 through page 36:6: 18 More specifically, when the control product is used in 19 instruments, such as those that employ the Coulter Model VCS 20 technology, which uses a reagent system such as described in 21 U.S. Patent No. 4,751,179, in order to distinguish at least to 22 population of leukocytes, (1) lymphoids (lymphocytes) and (2) 23 myeloids (neutrophils, monocytes, oesinophils and basophils), 24 the preferred suspension media enable the reaction between the 25
Consolidated Interferences 105,504 and 105,505 Decision of Motions 38 weaker lytic reagent and the non fixed red blood cells to occur 1 so that the red blood cells lyse while the leukocyte analogs 2 remain substantially unaffected, enabling each type of 3 leukocyte analog to be counted. 4 Dr. Wyatt has not explained why the fifth reference describes a 5 method for making or using a control analog for nucleated red blood cells. 6 On its face, the fifth reference facially is talking about counting leukocyte 7 analogs (white blood cell analogs). 8 7. 9 We have considered the remaining testimony by Dr. Wyatt. What we 10 find in that testimony is a convincing story as to why one skilled in the art, 11 given the disclosure of the involved Young applications, if not the first 12 Young application, would have been enabled to make and use analogs for 13 nucleated red blood cells if there has otherwise been a description that 14 making the analog would be useful. However, the written description 15 requirement and the enablement requirement of § 112 are separate 16 requirements. LizardTech, Inc. v. Earth Resource Mapping, Inc., 424 F.3d 17 1336 (Fed. Cir. 2005), rehearing and rehearing in banc denied, 433 F.3d 18 1373 (Fed. Cir. 2006). A disclosure which would enable one skilled in the 19 art to make and use particular subject matter does not necessarily describe 20 the subject matter. In this case, once someone suggests making an analog 21 for a nucleated red blood cell and asks how would it be done, all one need do 22 is refer to the first Young application and the remaining prior art relied and 23 known apparatus and practices in the art, all fully detailed by Dr. Wyatt in 24 his testimony. 25
Consolidated Interferences 105,504 and 105,505 Decision of Motions 39 But, the first Young application does not describe making and using a 1 control analog for nucleated blood cells beyond white nucleated blood cells. 2 C. 3 Because the claims presented by Young in the first Young application 4 were not patentable under 35 U.S.C. § 112 (written description) in that 5 application, Young cannot claim benefit under 35 U.S.C. § 120 of the filing 6 date of the first Young application. 7 Reason (2) 8 Claims essentially identical in all material respects to the involved 9 Young claims were presented by Young in the first Young application. The 10 first Young application is not "an application filed after the [Ryan] 11 application is published." Why? Because, the first Young application was 12 pending when the Ryan applications were published. 13 However, we have held that the claims which were presented did not 14 comply, in the first Young application, with the written description 15 requirements of 35 U.S.C. § 112. An issue in need of resolution with respect 16 to Reason (2) is the following: Must a claim presented in an attempt to 17 comply with 35 U.S.C. § 135(b)(2) also comply with the written description 18 requirement of 35 U.S.C. § 112? We hold that it must. 19 Young maintains that it complied with 35 U.S.C. § 135(b)(2) by 20 presenting the claims in the first Young application. Paper 57, page 16. 21 Young further maintains that those claims comply with 35 U.S.C. § 112. 22 Paper 57, page 19. Moreover, Young still further maintains that compliance 23 with 35 U.S.C. § 112 is not necessary to comply with 35 U.S.C. § 135(b). 24
Consolidated Interferences 105,504 and 105,505 Decision of Motions 40 Paper 104. In support of its position, Young cites In re Berger, 279 F.3d 1 975 (Fed. Cir. 2002). 2 In our view Berger did not involve the issue we now address. In 3 Berger, claim 7 was rejected inter alia under 35 U.S.C. § 135(b), but not 4 35 U.S.C. § 112, first paragraph. Claims 1-4, which were not rejected under 5 § 135(b), were rejected as being indefinite under 35 U.S.C. § 112, second 6 paragraph. We fail to appreciate how the facts in Berger involve the facts 7 before us. There was no contested § 120 issue involved in resolving the 8 § 135(b) issue. 9 We agree with Ryan that presentation of a claim to subject matter not 10 described in an application should not trigger compliance with § 135(b)(2). 11 First, it does not make sense. An applicant could put an "interfering" claim 12 in any pending application and then assert that the claim had been timely 13 filed. Second, the very repose which § 135(b)(2) seeks to impose would be 14 destroyed if an interference is declared with an application which fails to 15 describe the invention claimed in the application. Third, even if an 16 interference is declared, the applicant would lose on a threshold motion for 17 judgment based on a lack of a written description for the claimed subject 18 matter. 19 For completeness, we will note that in the case before us, the 20 Examiner had no occasion in the first Young application to look into the lack 21 of written description because a restriction requirement was made. 22 Ordinarily, the patentability on its merits of a claim is not reviewed when 23 making a restriction requirement. 24
Consolidated Interferences 105,504 and 105,505 Decision of Motions 41 Reason (3) 1 When an application is published its claims are also published. 2 Because, the scope of claims can change during prosecution, claims in an 3 issued patent may be materially different from those published. For 4 example, claims may have to be materially altered to avoid prior art cited by 5 the Examiner. Parks v. Fine, 773 F.2d 1577, 1579 (Fed. Cir. 1985); In re 6 Berger, 279 F.3d 975, 982-83 (Fed. Cir. 2002). 7 We have understood Ryan to argue that (1) whether published claim 8 scope changes is not relevant (because Ryan says the statute does not say so) 9 and (2), in any event, the scope of the claims in the Ryan patents is not 10 materially different from the scope of the claims as published. 11 A. 12 We disagree with Ryan's first contention—that even if the claims 13 of an issued patent are materially changed from any published claims, 14 § 135(b)(2) should be applied. 15 If the claims of a patent are materially narrower than the claims of a 16 published application, there would never need to be an interference 17 involving the published claims and the need to have copied the claims 18 becomes a moot issue. On the other extreme, if the published claims and the 19 patent claims are the same (i.e., no amendment made during prosecution), 20 then copying the published claims within one year makes sense and an 21 applicant would have needed to copy the claims within one year of 22 publication to avoid the § 135(b)(2) bar. 23 Assuming that an applicant timely "copies" a published claim, the 24 Examiner will not recommend, and there would be no need for, an 25
Consolidated Interferences 105,504 and 105,505 Decision of Motions 42 interference until both the published claim and the "copied" claim are 1 patentable, including being patentable over the prior art. 2 There are numerous "what ifs" which come to mind with respect to 3 examination when there is a § 135(b)(2) issue. Fortunately for all, we do not 4 have to answer all the imaginable "what ifs" in this case. One possible 5 "what if" may be worth considering, since it helps focus our analysis. 6 Suppose (1) A files an application, (2) A's application is published, (3) more 7 than one year after publication, B "copies" A's published claims, (4) since 8 day one the Examiner has rejected A's published claims over the prior art, 9 and (5) A has not been able to overcome the rejection. We will assume in 10 the example, that the prior art against A does not apply to B so B is "free" of 11 the prior art. Does the Examiner reject B under § 135(b)(2)? If so, is the 12 rejection provisional? If A never issues, does that mean B does not get a 13 patent even though B is patentable over the prior art? Or, does the Examiner 14 allow B's claims upon A's application becoming abandoned? If A ultimately 15 overcomes the prior art through material amendments and a patent issued to 16 A, does B forfeit a patent on claims which were patentable to B over the 17 prior art but which were (1) published and (2) unpatentable to A? 18 What becomes apparent from the way in which § 135(b)(2) "works" is 19 that a cautious applicant "copies" the published claim within one year of 20 publication and then waits to see what happens. If a patent issues, the 21 cautious applicant also "copies" the patent claims. Here that has not 22 occurred. Young has not timely presented claims. The claims in the 23 involved Young application were presented more than one year after 24 publication of the Ryan applications. 25
Consolidated Interferences 105,504 and 105,505 Decision of Motions 43 Between the extremes of (1) no amendment to the published claims 1 prior issuance of a patent and (2) amendments that all would agree are major 2 and substantial (e.g., to avoid the prior art), there are other possible 3 amendments. How should we treat those amendments? In our view, an 4 amendment which adds a non-material limitation to a published claim 5 should keep the § 135(b)(2) bar alive, whereas an amendment which is 6 material should not. We therefore interpret § 135(b)(2) to bar a claim only if 7 the "the claim of an application [which is] published" ultimately (1) issues as 8 published or (2) issues with no material changes. 9 B. 10 1. 11 In our view, the claims of the first Ryan patent (method of making a 12 control) do not contain material changes vis-à-vis the claims of the first 13 Ryan applications as published. On the other hand, the claims of the second 14 Ryan patent (method of using a control) contain material changes vis-à-vis 15 the claims of the second Ryan application as published. 16 In response to our invitation to submit post-oral argument 17 information, Ryan submitted inter alia Appendix 4 as part of Paper 106. 18 Appendix 4 comprises Part A and Part B. Appendix 4 is attached to this 19 opinion. 20 Part A compares the scope of the claims of the second Ryan 21 application as published with the claims of the second Ryan patent. 22 Part B compares the scope of the claims of the first Ryan application 23 as published with the claims of the first Ryan patent. Appendix 4, 24 page A4-12 through page A4-19. 25
Consolidated Interferences 105,504 and 105,505 Decision of Motions 44 2. 1 Appendix 4, Part B—first published Ryan application 2 The amendments to published Ryan claim 2 in the first published 3 Ryan application are revealed in Appendix 4, page A4-12-13. 4 It should be noted that claim 2 was a dependent claim when the first 5 Ryan application was published. Ex 2017, page 7. It was amended to 6 become an independent claim and ultimately issued as an independent claim. 7 Ex 1015, col. 13. 8 a. 9 A first amendment to claim 2, as published, as the limitation "wherein 10 said membrane maintains sufficient structural integrity to substantially 11 surround the remaining nucleus." Appendix 4, pages A4-13 through A4-19. 12 Young maintains that the amendment was material and Ryan 13 disagrees. 14 We agree with Ryan's observation on pages A4-12 through A4-13 of 15 the Appendix: The addition of the phrase was an immaterial change to 16 further clarify that the membrane remained intact around the nucleus. The 17 limitation essentially was already present in published claim 2, though in 18 different wording, by way of the phrases "membrane inclosing a nucleus and 19 cytoplasm" and "stabilizing said membrane with said nucleus remaining 20 therein." If the membrane did not have "sufficient structural integrity," it 21 would be destroyed upon removal of cytoplasm and there would be nothing 22 left to "stabilize." 23
Consolidated Interferences 105,504 and 105,505 Decision of Motions 45 b. 1 A second amendment to claim 2, as published, was "to give a 2 product." Appendix, page A4-13. The amendment was a formal 3 amendment to provide an antecedent in step c) for "admixing the product of 4 step c)" step d). 5 c. 6 Other amendments to published claim 2 are likely formal and 7 immaterial. 8 d. 9 The analysis with respect to published claim 2 is equally applicable to 10 published independent claim 11. 11 3. 12 Appendix 4, Part A—second Ryan published application 13 The amendments to published Ryan independent claim 1 in the second 14 published Ryan application are revealed in Appendix 4, pages A4-1 through 15 A4-13. 16 One amendment made to published Ryan claim 1 was addition of the 17 limitation "and wherein the cytoplasm of the stabilized blood cell has been 18 substantially removed from within said membrane." Appendix 4, 19 page A4-1. 20 Ryan concedes that the addition was made in view the Examiner's 21 rejections over the prior art. Appendix 4, page A4-1. 22 No convincing explanation is presented by Ryan why the amendment 23 is not a material change. What does Ryan have to say? To find out, we turn 24 to pages 6-7 of Paper 106: 25
Consolidated Interferences 105,504 and 105,505 Decision of Motions 46 During prosecution of the '137 patent [the second Ryan 1 patent], Ryan's claims as published were rejected over prior art 2 disclosing a control containing a nucleated blood cell wherein 3 the source blood cell used was fixed (but no cytoplasm was 4 removed). (Exhibit 1064, at pp.4-11) In response to this 5 rejection, Ryan added the following limitation: "and wherein 6 the cytoplasm of the stabilized blood cell has been substantially 7 removed from within said membrane." (Ex 1065 at pp. 3-5 and 8 7-8). Though new to the claims corresponding to the '137 9 patent [the second Ryan patent], this limitation already existed 10 in the published claims corresponding to the '563 patent [the 11 first Ryan patent], which published on the same day. 12 Nevertheless, for purposes of 135(b)(2) Ryan relies on the 13 published claims corresponding to the '563 patent [second Ryan 14 patent] containing this limitation (discussed below). 15 16 In our view, the claims in a first published application should not be 17 relevant to a determination of whether an amendment to a claim in a second 18 published application adds a material limitation. Proper notice under 19 § 135(b)(2) should not have to turn on whether a third-party can decipher 20 limitations in more than one application to divine what it is that the third- 21 party must present in its application. If § 135(b)(2) is designed to give an 22 applicant "repose," then the applicant needs to give notice of what it is that 23 will be "reposed." 24
Consolidated Interferences 105,504 and 105,505 Decision of Motions 47 Decision on Ryan Motion 2 1 For the reasons given, Ryan Motion 2 is granted as to Interference 2 105,505 [105,504] and a judgment will be entered against Young (method of 3 using a control). Ryan Motion 2 is denied as to Interference 105,504 4 [105,505] (method of making a control). 5 6 F. Ryan Motion 1 7 Pursuant to 37 C.F.R. § 41.125(a), we exercise discretion to consider 8 next Ryan Motion 1. 9 Ryan Motion 1 seeks judgment against Young based on Young's 10 alleged failure to comply with the written description and enablement 11 provisions of the first paragraph of 35 U.S.C. § 112. 12 Scope of involved Young claims 13 The involved Young claims were original claims in the involved 14 Young applications. See Ex 1003, Preliminary Amendment filed with 15 application; Ex 1004, Preliminary Amendment filed application. We will 16 note that it would be helpful to the Board and an opponent if a large exhibit 17 has consecutive page numbers starting with 1 on the first page 18 When the same claims were presented in the first and second Young 19 applications, they were presented by amendment and were not original 20 claims. 21 The term "nucleated blood cells" would be understood by one skilled 22 in the art to be a reference to both nucleated white blood cells and nucleated 23 red blood cells. 24 Since "nucleated blood cells" include both nucleated white blood cells 25 and nucleated red blood cells, the involved Young claims cover making or 26
Consolidated Interferences 105,504 and 105,505 Decision of Motions 48 using control analogs for nucleated white blood cells and nucleated red 1 blood cells. 2 Written description 3 Original claims form part of the original specification. In re 4 Anderson, 471 F.2d 1237, 1244 (CCPA 1973). 5 The Young disclosure explicitly describes numerous nucleated white 6 blood species and nucleated blood cells. Nucleated blood cells include 7 nucleated red blood cells. But, that does not take away the fact that as filed 8 the Young involved applications describe "nucleated blood cells." 9 Ryan maintains that since all Young describes, by way of examples, is 10 nucleated white blood cells that Young should not be allowed to "cover" 11 nucleated red blood cells. In support of its argument, Ryan cites several 12 Federal Circuit cases. Paper 69, pages 3-4. We have considered the cited 13 case, but must note that each written description (an issue of fact) is 14 dependent on the facts in each case. Accordingly, it will not often occur that 15 one written description holding will control a different written description 16 issue. In re Driscoll, 562 F.2d 1245, 1249 (CCPA 1977); accord Unocal v. 17 Atlantic Richfield Co., 208 F.3d 989, 1001 (Fed. Cir. 2000). 18 In re Curtis, 354 F.3d 1347, 1357-58 (Fed. Cir. 2004), involved a 19 situation where Curtis filed a continuation-in-part and added disclosure. The 20 continuation-in-part described a “genus of friction enhancing agents.” On 21 the other hand an earlier parent did not describe the genus. The Federal 22 Circuit recognized that a continuation-in-part can have additional disclosure 23 and that what is described in the continuation-in-part may not be described 24 in a parent application. In our view that is what has occurred in the case 25
Consolidated Interferences 105,504 and 105,505 Decision of Motions 49 before us. By virtue of having added the language “nucleated blood cell” in 1 the involved Young applications, Young has added disclosure not present in 2 its parent first and second Young applications. We have not overlooked the 3 fact that Young characterizes the involved Young applications as 4 “continuations” of the earlier first and second Young applications. Because 5 the involved Young applications contain additional disclosure, albeit in the 6 original claims, those applications are "continuations-in-part" of the earlier 7 first and second Young applications. The "continuation" label is not magic; 8 what matters is whether additional disclosure is added. Here additional 9 disclosure was added. 10 Noelle v. Lederman, 355 F.3d 1343, 1350 (Fed. Cir. 2004), is similar 11 to In re Curtis and involved an issue of whether a parent application 12 described an invention claimed in a subsequent continuation-in-part. The 13 parent description of a murine antibody did not satisfy the written 14 description requirement for what the court referred to as human and genus 15 antibody claims. Noelle did not hold the claims of the involved Noelle’s 16 involved application as being unpatentable based on any alleged failure to 17 comply with the written description requirement. 18 Tronzo v. Biomet, Inc., 156 F.3d 1154, 1158 (Fed. Cir. 1998), like the 19 two prior cases, involved a continuation-in-part versus parent disclosure. 20 Here we are not concerned with any parent application. The court held that 21 the narrow language of the parent application could not be said to disclose 22 the hemispherical shape of the claims of the patent which issued on the basis 23 of the continuation-in-part application. 24
Consolidated Interferences 105,504 and 105,505 Decision of Motions 50 LizardTech Inc. v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1 1346 (Fed. Cir. 2005), reh'g en banc denied, 433 F.3d 1373 (Fed. Cir. 2006), 2 holds that it is unnecessary to spell out every detail of an invention in a 3 specification. Rather, only sufficient information must be present to 4 convince a person having ordinary skill in the art that the inventor possessed 5 the invention. In this case, Young not only describes numerous species of 6 nucleated white blood cells, but “nucleated blood cells” as well. The 7 uncontradicted evidence shows that one skilled in the art views “nucleated 8 blood cells” as including both nucleated white blood cells and nucleated red 9 blood cells. 10 Enablement 11 Ryan maintains, in support of its motion, that the involved Young 12 applications do not enable one skilled in the art to make and use nucleated 13 red blood cell controls. In presenting its argument, Ryan in effect would 14 confine the relevant disclosure solely to the specification of the involved 15 Young applications. 16 A recent Federal Circuit opinion provides a road map for analysis of 17 the enablement issue in this case. Sitrick v. Dreamworks, LLC, Appeal 18 2007-1174 (Fed. Cir. Feb. 1, 2008). The appeal involved integrating a user's 19 audio signal or visual image into a pre-existing video games or movies. The 20 district court held patents invalid for lack of enablement as to movies, 21 expressing no views on enablement with respect to video games. The patent 22 claims encompassed both video games and movies. The district court found 23 that patents did not explain how an Adaptor Interface System (IAIS) would 24 function outside of a video game. The defendant's experts did not believe 25
Consolidated Interferences 105,504 and 105,505 Decision of Motions 51 disclosure regarding video games would enable use of the IAIS in movies. 1 The Federal Circuit held that the full scope of a claimed invention must be 2 enabled. As noted by the Federal circuit, enabling the full scope of each 3 claim is part of the quid pro quo of the patent bargain. Accordingly, because 4 the claims cover both movies and video games, the patents must enable both 5 embodiments. An enablement analysis begins with the specification. The 6 Federal Circuit agreed with the district court that the patents in suit did not 7 describe how the substitution and integration of a user image would be 8 accomplished in movies. The defendant's experts explained that one skilled 9 in the art would not have been able to take the teachings regarding video 10 games and apply them to movies. Lastly, the Federal Circuit noted that 11 enablement is determined from the vantage point of one skilled in the art. 12 The very considerations which lead Sitrick to agree with the district 13 court concerning lack of enablement as to movies, leads us to a contrary 14 conclusion in this case with respect to nucleated red blood cells. Initially, 15 we will note that Ryan does not challenge enablement with respect to 16 nucleated white blood cells. Ryan's "beef" is that Young does not enable 17 nucleated red blood cells. The claims here, like those in Sitrick, cover two 18 embodiments: making and using control analogs for both nucleated white 19 blood cells and nucleated red blood cells. In this case, just as the district 20 court found that patents do not explain how IAIS would function outside of a 21 video game, we conclude that the involved Young applications do not 22 explicitly tell one skilled in the art how to make and use control analogs for 23 nucleated red blood cells. Where this case differs from Sitrick is that 24 whereas defendant's experts did not believe disclosure regarding video 25
Consolidated Interferences 105,504 and 105,505 Decision of Motions 52 games would enable use of the IAIS in movies, here one skilled in the art, 1 given the Young disclosure, would have been enabled to make and use 2 control analogs for nucleated red blood cells. Accordingly, unlike Sitrick, 3 the full scope of a claimed invention is enabled. While an enablement 4 analysis begins with the specification, the analysis includes what is known in 5 the art and what one skilled in the art would know how to do given a 6 disclosure in a specification. Webster Loom Co. v. Higgins, 15 Otto 7 (105 U.S.) 580, 586 (1881) (an inventor may begin a description of an 8 invention at the point where his invention begins, and describe what he has 9 made that is new, and what it replaces of the old; that which is common and 10 known is as if it were written out in the patent and delineated in the 11 drawings). In Sitrick, the defendant's experts convincingly explained that 12 one skilled in the art would not be able to take the teachings regarding video 13 games and apply them to movies. However, in this case, Dr. Wyatt has 14 explained why the teachings of Young enable making and using control 15 analogs for nucleated red blood cells. We accept his enablement testimony 16 and explanation. 17 For example, Ryan argues that the apparatus described in the involved 18 Young application would not be used by one skilled in the art to analyze 19 nucleated red blood cells. Dr. Wyatt has a satisfactory answer to Ryan's 20 argument. Ex 1041, page 21, ¶ 159 et seq. In this respect, we note that 21 Dr. Wyatt's position is supported by prior art literature. 22 See, e.g., Ex 1041, page 22, ¶¶ 161 and 163. 23 With respect not only to enablement, but the written description issue, 24 Ryan maintains that the art is unpredictable. Specifically, Ryan seems to be 25
Consolidated Interferences 105,504 and 105,505 Decision of Motions 53 of the view that what works with nucleated white blood cells will not work 1 with nucleated red blood cells. In our view, Dr. Wyatt answers Ryan's 2 concern. See, e.g., Ex 1041, page 29, ¶ 202 et seq. Dr. Wyatt also tells us 3 that the level of skill in the art is relatively high and that one skilled in the art 4 knows how to use the various analytical tools known in the art. 5 Observations 6 Some observations about the case before us are believed to be in 7 order, particularly what Ryan has not alleged, and cannot now allege. 8 First, Ryan has not moved to deny Young earlier constructive 9 reductions to practice accorded to Young in the declaration. Perhaps no 10 motion was filed because Ryan recognizes that Young describes nucleated 11 white blood cell species and an earlier constructive reduction to practice can 12 be based on a single enabling description of an embodiment within the scope 13 of the count. 14 Second, Ryan did not move for judgment based on unpatentability 15 over the prior art. Ryan could have maintained that the claims in the 16 involved first and second Young applications are not entitled to benefit of 17 the first and second Young applications under 35 U.S.C. § 120. The prior 18 art would have been any prior art, including prior Young patents, which 19 would be prior art under § 102(b). But, Ryan did not timely seek 20 authorization to file such a motion and therefore patentability of the 21 involved Young claims over the prior art is not before us. Cf. Brand v. 22 Miller, 487 F.3d 862, 869 (Fed. Cir. 2007) (in an interference the Board's 23 role is one of an impartial adjudicator of an adversarial dispute between two 24 parties). We decline to consider in these interferences the patentability over 25
Consolidated Interferences 105,504 and 105,505 Decision of Motions 54 the prior art of the involved Young claims. The Examiner will be free to 1 consider patentability when the Young applications return to ex parte 2 prosecution after the interferences. 3 Decision on Ryan Motion 1 4 For the reasons given, Ryan Motion 1 is denied. 5 G. Young motion 1 6 Young Motion 1 seeks judgment against Ryan based on alleged 7 unpatentability over the prior art. 8 We decline at this time to reach the motion. 9 With respect to Interference 105,505, a judgment is being entered 10 against Young for failure to comply with the requirements of 35 U.S.C. 11 § 135(b)(2). Since § 135(b)(2) is a statute of repose, in our view Young no 12 longer has standing in the interference. Our decision not to reach Young 13 Motion 1 with respect the Ryan patent involved in Interference 105,505 is 14 without prejudice to Young seeking reexamination of the claims of the 15 patent on the basis of the prior art relied upon and cited in its motion. 16 With respect to Interference 105,504, we have denied Ryan Motion 2 17 based on alleged repose under 35 U.S.C. § 135(b)(2). We have also denied 18 Ryan Motion 1 based on alleged non-compliance with the first paragraph of 19 35 U.S.C. § 112. 20 Ordinarily, we might proceed to consider Young Motion 1. However, 21 we note an over five-year difference in constructive reductions to practice 22 accorded to the parties. While Ryan maintains in its priority statement that it 23 conceived and actually reduction to practice before Young's earliest 24 accorded date, Ryan will not only have to establish its case, but will be faced 25
Consolidated Interferences 105,504 and 105,505 Decision of Motions 55 with explaining why it did not suppress or conceal the invention over a four- 1 year period prior to filing its application. Alternatively, Ryan will have to 2 explain why it was diligent from for the five years prior to Young's accorded 3 dates until Ryan's constructive reduction to practice. 4 While we will not prejudge priority, it would appear that Ryan has a 5 substantial hurdle to overcome. Accordingly, we exercise our discretion to 6 proceed to priority and allow Ryan to put on its case. We note that Young 7 did not file a priority statement, so Young is restricted to its earliest 8 accorded date. 9 If Ryan prevails on priority, then we will take up Young Motion 1. If 10 Ryan does not prevail on priority, then patentability over the prior art 11 becomes moot. 12 H. Motions to exclude evidence 13 Ryan Miscellaneous Motion 4 14 Ryan seeks exclusion of (1) Ex 1033, (2) Ex 1036, (3) Ex 1039, 15 (4) Ex 1051, (5) Ex 1073, and (6) Ex 1093. Since we have not considered or 16 relied on these exhibits, Ryan's motion to exclude is dismissed as moot. 17 Young Miscellaneous Motion 5 18 Young seeks exclusion of (1) Ex 2060 (¶¶62-63), (2) Ex 2063, 19 (3) Ex 2070 through Ex 2077, (4) Ex 2083, (5) Ex 2107 (¶¶ 4-5, 24-30, 20 38-40), and (6) Ex 2109. Since we have not considered or relied on these 21 exhibits, Young's motion to exclude is dismissed as moot. 22 I. Young Miscellaneous Motion 4 23 Young Miscellaneous Motion 4 (Paper 77) seeks entry of an order 24 striking Ryan Reply 1 (Paper 69). 25
Consolidated Interferences 105,504 and 105,505 Decision of Motions 56 According to Young, in Ryan Reply 1, Ryan seeks to file a motion for 1 judgment against Young based on 35 U.S.C. § 103. In the reply, Ryan 2 suggests that if certain arguments of Young are accepted, then Young the 3 involved Young claims are unpatentable over the prior art. 4 Ryan did not obtain authorization to file a motion for judgment 5 against Young based on the prior art. We have considered the statements in 6 the reply only as argument. As noted earlier in this opinion, we have not 7 considered whether the involved Young claims are unpatentable over the 8 prior art because Ryan did not timely seek, and has not timely raised, the 9 issue of whether the involved Young claims are unpatentable over the prior 10 art. 11 Since we have not considered on the merits the portion of Ryan Reply 12 1 which Young finds objectionable, we will dismiss Young Miscellaneous 13 Motion 4 as moot. 14 Our dismissal should not be construed as precluding the Examiner 15 from rejecting the involved Young claims on the ground suggested in Ryan 16 Reply 1 when ex parte prosecution is resumed. 17 J. Young Responsive Motion 3 18 Young Responsive Motion 3 proposes to add claims to the involved 19 Young applications in the event Ryan Motion 1 is granted. Since Ryan 20 Motion 1 is being denied, there is no need to consider Young Responsive 21 Motion 1. Young Responsive Motion is therefore dismissed. 22
Consolidated Interferences 105,504 and 105,505 Decision of Motions 57 K. Order 1 Upon consideration of the record, and for the reasons given, it is 2 ORDERED that Ryan Motion 1 seeking judgment based on the 3 first paragraph of 35 U.S.C. § 112 is denied as to both Interference 105,504 4 and Interference 105,505. 5 FURTHER ORDERED that Ryan Motion 2 for judgment based 6 on repose under 35 U.S.C. § 135(b)(2) is granted [denied] as to Interference 7 105,505 and is denied [granted] as to Interference 105,504. 8 FURTHER ORDERED that further consideration of Young 9 Motion 1 alleging unpatentability over the prior art is deferred until the 10 priority phase of Interference 105,504 [105,505]. 11 FURTHER ORDERED that Young Motion 3 for leave to add 12 claims to the involved Young applications is dismissed because Ryan 13 Motion 1 has been denied. 14 FURTHER ORDERED that Ryan Miscellaneous Motion 4 to 15 exclude evidence is dismissed as moot. 16 FURTHER ORDERED that Young Miscellaneous Motion 4 to 17 strike Ryan Reply 1 is dismissed as moot. 18 FURTHER ORDERED that Young Miscellaneous Motion 5 to 19 exclude evidence is dismissed as moot. 20
Consolidated Interferences 105,504 and 105,505 Decision of Motions 58 FURTHER ORDERED that a copy of this [AMENDED] 1 DECISION ON MOTIONS shall be placed in the file of Interference 2 105,504 and the file of Interference 105,505. 3 FURTHER ORDERED that a copy of this [AMENDED] 4 DECISION ON MOTIONS shall be placed in the files of (1) Ryan Patent 5 6,723,563 B2, (2) Ryan Patent 6,653,137 B2, (3) Young 10/909,561, and (4) 6 Young application 10/909,594. 7
Consolidated Interferences 105,504 and 105,505 Decision of Motions 59 cc (via electronic mail): 1 2 Attorney for Ryan 3 (real party in interest 4 Streck Laboratories, Inc.): 5 6 Janelle D. Waack, Esq. 7 Melinda L. Patterson, Esq. 8 HOWREY, LLP 9 1111 Louisiana, 25 th Floor 10 Houston, TX 77002-5242 11 Tel: (713)787-1686 (Waack) 12 Tel: (713)787-1592 (Patterson) 13 Fax: (713)787-1440 14 Email: waackj@howrey.com 15 Email: pattersonm@howrey.com 16 17 18 Attorney for Young 19 (real party in interest 20 Beckman Coulter, Inc.) 21 22 Herbert D. Hart III, Esq. 23 McANDREWS, HELD & MALLOY, Ltd. 24 500 W. Madison St., 34 th Floor 25 Chicago, IL 60661 26 Tel: (312)775-8000 27 Fax: (312)775-8100 28 Email: hhart@mcandrews-ip.com 29 Email: mharlin@mcandrews-ip.com 30
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